FDA 510(k) Application Details - K243646

Device Classification Name	More FDA Info for this Device
510(K) Number	K243646
Device Name	Ziehm Solo FD
Applicant	Ziehm Imaging GmbH Lina-Ammon-Strasse 10 Nuremberg 90471 DE Other 510(k) Applications for this Company
Contact	Cornelia Schildbach Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	03/17/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review